CEE Regulatory Affairs and Pharmacovigilance Specialist

About the role

ProPharma, a consultancy advising biotech, med device and pharmaceutical organisations, is looking for a CEE Regulatory Affairs and Pharmacovigilance Specialist. The role covers regulatory affairs (RA), pharmacovigilance (PV) and safety monitoring in the countries where ProPharma operates, performed independently but with input from senior ProPharma staff, for medicinal and non-medicinal products.

Key responsibilities

• Regulatory affairs: prepare marketing authorization applications, variations, notifications and renewals, supporting documentation, product recalls and price/reimbursement matters; review marketing materials against the registered dossier and local law; monitor local RA legislation and notify colleagues and partners; advise partners on local regulatory topics; train RA staff and maintain RA documentation; act as responsible person for documentation for MA applications, variations and renewals where applicable.
• Pharmacovigilance: monitor local and EU PV legislation and Competent Authority web pages; collect, assess, file and archive Individual Case Safety Reports (ICSRs); follow up safety information with healthcare professionals and consumers; expedite reporting to local authorities and Eudravigilance; screen medical and scientific literature and company websites for safety signals; track and submit Periodic Safety Update Reports (PSURs) and AddCOs; reconcile safety data with the partner's global PV department; handle medical information enquiries and quality complaints with safety impact; cooperate with the EU QPPV on the PSMF and signal management; participate in PV audits and inspections; develop and maintain PV SOPs and training records; act as EU QPPV/QPPV deputy or LPVRP/LPVRP deputy for specific projects where applicable.

Required profile

• B.Sc./B.A. or higher in medicine, pharmacy, dental medicine or medical biochemistry.
• Advanced theoretical and practical knowledge of local legislation in all countries where ProPharma operates.
• Experience with European and national regulatory submissions and agency interactions.
• Experience leading successful sub-projects and supporting client relationships.

Required skills

• Intermediate to advanced English (spoken and written).
• High computer literacy, strong organization and multitasking skills.
• Ability to analyze recurring issues, work independently on complex regulatory tasks and share knowledge.